Class 2 Device Recall EVIS EXERA III

• Date Initiated by Firm: October 16, 2023
• Date Posted: November 29, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0416-2024
• Recall Event ID: 93335
• 510(K)Number: K131780
• Product Classification: Colonoscope and accessories, flexible/rigid - Product Code FDF
• Product: GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Code Information: UDI-DI 04953170305290 Serial Numbers 2515895, 2312905, 2628532
• Recalling Firm/ Manufacturer: Aizu Olympus Co., Ltd.; 3 Chome 1-1; Niiderakita; Aizuwakamatsu Japan
• For Additional Information Contact: Cynthia Ow; 647-9993203
• Manufacturer Reason for Recall: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
• FDA Determined Cause: Process control
• Action: On October 16, 2023, the firm notified affected customers through URGENT MEDICAL DEVICE REMOVAL letters. Customers were instructed to inspect their inventory and identify affected devices. Affected devices should be quarantined and not used. Olympus Customer Solutions will contact customers by phone and email to arrange the return and repair of the affected product. If you require additional information, please do not hesitate to contact Olympus at 647-999-3203 or Cynthia.Ow@Olympus.com.
• Quantity in Commerce: 24 incorrectly repaired units
• Distribution: Domestic distribution to FL, KY, MA, NJ, NY, and PA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FDF